In patients with septic shock, treatment with intravenous vitamin C, hydrocortisone, and thiamine does not lead to more rapid resolution compared with intravenous hydrocortisone alone, according to the results of a multicenter, open-label, randomized clinical trial (VITAMINS; ClinicalTrial.gov Identifier: NCT03333278) published in JAMA.
It is unknown whether vitamin C, hydrocortisone, and thiamine are more effective than hydrocortisone alone in expediting resolution of septic shock; therefore, researchers sought to determine whether this combination compared with hydrocortisone alone improves the duration of time alive and free of vasopressor administration in 216 patients with septic shock in 10 intensive care units in Australia, New Zealand, and Brazil.
The first patient was enrolled on May 8, 2018, and the last on July 9, 2019, with the final date of follow-up on October 6, 2019. A total of 109 were randomly assigned to the intervention group consisting of intravenous vitamin C (1.5 g every 6 hours), hydrocortisone (50 mg every 6 hours), and thiamine (200 mg every 12 hours) or to the control group (n=107) consisting of intravenous hydrocortisone (50 mg every 6 hours) alone until shock resolution or up to 10 days.
Researchers found that up to day 7, time alive and vasopressor free was 122.1 hours in the intervention group and 124.6 hours in the control group; the median of all paired differences was -0.6 hours (P =.83). Of 10 prespecified secondary outcomes, 9 showed no statistically significant difference. The 90-day mortality rate was 28.6% (30/105) in the intervention group and 24.5% (25/102) in the control group. In addition, no serious adverse events were reported.
The study authors concluded, “In patients with septic shock, treatment with intravenous vitamin C, hydrocortisone, and thiamine, compared with intravenous hydrocortisone alone, did not significantly improve the duration of time alive and free of vasopressor administration over 7 days.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Fujii T, Luethi N, Young PJ, et al; for the VITAMINS Trial Investigators. Effect of vitamin C, hydrocortisone, and thiamine vs hydrocortisone alone on time alive and free of vasopressor support among patients with septic shock. The VITAMINS randomized clinical trial. JAMA. 2020;323(5):423-431.